Medtronic Advances APOLLO Clinical Trial for Intrepid Transcatheter Mitral Valve Replacement System

Mar 08, 2024 00:02 CST Updated 00:02

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source of the article:Heart NotCome;Editor:Bai Xiaofei

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Heart Future

Recently, the United StatesHackensack Meridian Jersey Shore University Medical CenterAnnouncementParticipate in Medtronic's APOLLO Clinical Trial, the trial is ongoingEvaluationIntrepid Transcatheter Mitral Valve Replacement System (TMVR)Safety and Effectiveness, inTreatment for patients with moderate to severe or severe symptomatic mitral regurgitation (MR) who are not suitable for transcatheter repair or surgery. This isOne of the only two hospitals in New Jersey providing the trial to patients。

Intrepid TMVR is aHeart Valve, Aiming atHelp alleviate mitral regurgitation, ensuring blood flows through the heart in a predetermined direction. This is aComplete Mitral Valve Replacement, which can be minimally invasively implanted through the patient's femoral vein via a catheter or tube.

As a leading provider of high-quality cardiac surgery and diagnostic testing in New Jersey and an academic institution, Hackensack Meridian Jersey Shore University Medical Center offers patientsThe Most Advanced Clinical Trials for Heart Valve Disease and Congestive Heart Failure Treatment。

As part of a global clinical trial,The Intrepid valve has been used to treat more than 350 patients.。

Currently, Medtronic's APOLLO trial is evaluating the Intrepid TMVR system for use in patients with severe mitral regurgitation (MR).An experimental groupEvaluationPatients with primary or secondary mitral regurgitation who are not suitable for traditional mitral valve surgery or transcatheter edge-to-edge repair (TEER)；Another experimental groupEvaluationPatients with severe symptoms of mitral regurgitationThese patients are considered unsuitable for conventional surgery for mitral annular calcification (MAC).

So far, patients participating in this study have received the Intrepid TMVR system,The system usesThrough the apical approach, compress the valve within a hollow catheter, then transmit it through the ribs to the heart.。

With the approval of the Investigational Device Exemption (IDE), APOLLO researchers will have an additional option,That is, the valve is inserted into the femoral vein through an inguinal incision.，This is the majority of transcatheter proceduresPreferred Method。Meanwhile,Intrepid valve is also undergoing early feasibility trial research in the tricuspid field., Medtronic is trying to find new technologies to crack the难题.

# Intrepid Transcatheter Mitral Valve Replacement System

▲Intrepid Transcatheter Mitral Valve Replacement System (Image SourceOfficial CompanyNetwork)

Intrepid Valve AdoptedDouble-layer Stent DesignThe outer stent is soft and contains barbs, which can pierce into the mitral valve leaflets to secure the entire device in place; the inner stent serves as the functional stent, with three bovine pericardial leaflets sutured inside.

Both stents are cylindrical in shape,The peripheral stent can deform with cardiac contraction.To reduce left ventricular outflow tract obstruction and protect the contractile function of the cardiac base;Internal stents can also avoid interference from external stents., thereby better enhancing the function of the valve. Additionally, the design of the peripheral stent can also make the diameter of the artificial annulus smaller,Reduce the stress on the valve leaflets, thereby extending the life of the valve.(The lifespan of bioprosthetic valves is related to both the height of the leaflet suspension and the valve orifice area.)

# Product Features and Analysis

(1) Minimal trauma

Intrepid Transfemoral Approach vs. Transapical ApproachCan significantly reduce intraoperative trauma to patients. However, according to the 2021 TCT report, the incidence of vascular complications with the femoral vein approach version of Intrepid was as high as 40% (6/15), which may be mainly due to the large delivery outer diameter (35F) of the entire system. Therefore,The Intrepid system will further reduce the outer diameter of the entire delivery system to 29F in order to decrease vascular complications.。

▲Image SourceOfficial CompanyNet

（2) Stable Anchoring

The mitral valve has complex working conditions compared to the aortic valve. The position of the mitral valve and the structure of the mitral annulus increase the difficulty of accurately placing an artificial valve, and the valve must remain stable and not shift after implantation.

The anchoring methods of TMVR include end tethers (Abbott Tendyne); radial interference (Medtronic Intrepid); barbs (Medtronic Intrepid); anchoring arms (Edwards Evoque); and valve-in-ring (Edwards Sapien M3 and Highlife).Medtronic's Intrepid adopts a dual anchoring mode of radial interference and barbs.Success rate of femoral valve anchoring: 93%One patient was converted to surgery due to valve displacement after implantation.

▲Image SourceOfficial CompanyNet

(3) Avoid paravalvular leakage

Similar to aortic valve design, almost all TMVR valves currentlyAll adopt the method of using sealing membranes to prevent paravalvular leakage., but due to the complex D-shaped three-dimensional saddle structure of the mitral valve annulus, it poses a significant challenge for valve design.

Medtronic'sIntrepid valve adopts a dual-layer stent design with inner and outer frames., the outer stent is sutured with a dense sealing membrane, and the outer stent is relatively soft and contains multiple rows of barbs. After the valve is released, the barbs on the outer stent can penetrate into the native valve leaflets,Not only can it serve as an anchor, but also the larger skirt seal can effectively prevent paravalvular leakage.; The inner stent is sutured with three bovine pericardial leaflets, which play a role in opening and closing during the heart's diastole and systole.

CurrentlyMedtronic's Intrepid valve hasTwo sizes: 42mm and 48mm, the 54mm size valve is under development, where 42mm, 48mm, and 54mm refer to the outer stent sizes, and the inner stent is available only in the 27mm size.

▲Image SourceOfficial CompanyNet

(4) Avoid outflow tract obstruction

Medtronic's Intrepid valve has a dual-layer frame with both inner and outer layers featuring a circular structure,The outer stent can change with the contraction of the heart, effectively reducing the obstruction of the left ventricular outflow tract.；The inner stent is not interfered with by the outer stent., which can protect bovine biological tissue valves,Ensure Blood Flow Direction。

Early Intrepid patients were selected using the end-systolic evaluation method.Left Ventricular Outflow Tract Area (Neo-LVOT），The screening failure rate is as high as 40%.，With the continuous progress of clinical trials and the accumulation of operators' experience, researchers have adopted multi-phasic evaluation and early systolic evaluation to assess Neo-LVOT in patients who were initially excluded.Significantly increased the proportion of patient enrollment,Screening failure rate drops to 20%。

With the continuous improvement of equipment and the accumulation of operators' experience, such as avoiding LVOT through alcohol septal ablation and LAMPOON (intentional laceration of the anterior mitral valve leaflet), it is believed that more and more patients with mitral regurgitation will benefit from TMVR in the future, significantly improving their quality of life.

▲Image SourceOfficial CompanyNet

# Results of Early Feasibility Study

Early Clinical Study Results of the Intrepid Transfemoral Mitral Valve Replacement System Reported on 26 Selected PatientsFinally, 15 patients completed the implantation., one patient converted to open chest surgery. The ratio of primary reflux to secondary reflux was approximately 2:1, with an average patient age of 80 years, and most cases involved severe mitral regurgitation.

The data shows Intrepid's strong ease of use and the advantages of the transfemoral approach.The average instrument operation time was 46 minutes, and the average postoperative hospital stay was 5 days.The 30-day postoperative follow-up results also demonstrated the superior therapeutic efficacy of Intrepid.All-cause mortality rate in 15 patients is 0%。The incidence of stroke, reintervention (or surgery), pacemaker implantation, and renal function impairment of grade 2 or higher was 0.. Immediately after surgery, mitral regurgitation decreased to trace or less (MR≤1+) in all patients,100% of patients had complete disappearance of mitral regurgitation 30 days after surgery.。

Compared with similar products, the Intrepid Transfemoral Septal Mitral Valve Replacement System has achieved the highest standards in both safety and efficacy; and itsVascular complications with relatively high incidence ratesis also expected to pass throughSignificant Reduction in Outer Diameter of the Next-Generation Femoral Delivery SystemAnd improved。

▲Image SourceOfficial CompanyNet

AboutMedtronic

Medtronic (Medtronic, NYSE: MDT), founded in 1949, is headquartered in Minneapolis, Minnesota, USA. It is a global leader in medical technology, dedicated to providing lifelong treatment solutions for patients with chronic diseases.With over 95,000 employees,Innovative solutions have expanded to more than 70 key disease areas.。

Main Products of MedtronicCoverageArrhythmia, Heart Failure, Vascular Disease, Heart Valve Replacement, Extracorporeal Cardiac Support, Minimally Invasive Cardiac Surgery, malignant and non-malignant pain, ataxia, diabetes, gastrointestinal diseases, urinary system diseases, spinal diseases, neurological disorders, and surgeries in ophthalmology, otolaryngology, and other related fields.

On February 20, 2024, Medtronic announced its third-quarter financial report for the fiscal year 2024, which ended on January 26. The report showsThe company's quarterly revenue was $8.1 billion (approximately 58.2 billion RMB)., an increase of 4.7% year-over-year; net profit for the quarter was US$1.34 billion, an increase of 8.8% year-over-year.

(For details, see:Medtronic Reports $58.2 Billion in Financial Results! Business Termination and Executive Departure）

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